Cemar Electro Inc. MAXX-606/607 Patient Positioning Laser. Installation and Set-up Manual

Transcription

1 Cemar Electro Inc. MAXX-606/607 Patient Positioning Laser Installation and Set-up Manual Cemar Electro Inc th Avenue Lachine, QC H8T 3J8 Canada Phone: Fax: Toll free:

2 WARNING This manual contains the latest information at the time of publication. Cemar Electro Inc. reserves the right to revise this manual without notice. The MAXX-606/607 Patient Positioning Laser is intended for use only by physicians qualified in diagnostic radiology and radiation therapy and experienced in marking patients utilizing patient positioning lasers or by therapists at the specific direction of such a qualified physician. It is the sole responsibility of the physician to judge whether the use of the MAXX-606/607 Patient Positioning Laser is clinically appropriate. Comment [KO1]: This text was revised from the MAXX1100. Please confirm if the intended user details are correct and pertain to the MAXX606. Comment [MS2]: Yes, this is good. Page 2

3 TABLE OF CONTENTS Section 1: Introduction Section 2: Intended Usage Section 3: Laser Safety Considerations 3.1 Signal Words 3.2 General Safety 3.3 Protective Eyewear 3.4 Laser Specifications 3.5 Safety Labels for MAXX-606/607 Units 3.6 Storage Section 4: Power Supply Section 5: Treatment Room Preparation 5.1 General Room Layout 5.2 Room Specifications Section 6: Laser Installation 6.1 Pre-Installation 6.2 Installation Instructions Mounting Options 6.3 Operator Controls Section 7: System Maintenance 7.1 Repair and Servicing 7.2 Maintenance and Cleaning Section 8: System Maintenance 8.1 Technical Support 8.2 Customer Service 8.3 Contact Information Section 9: Warranty

4 SECTION 1: INTRODUCTION This Installation and User s Guide includes all the information you need to safely and efficiently install, operate, and maintain your MAXX-606/607 Patient Positioning Laser. The MAXX-606/607 is a manual patient positioning system. The system is based the original CL-606 series but takes advantage of a streamlined and economic design along with the latest laser technology to offer a simple laser with minimal maintenance. Easy to install, the MAXX-606/607 embodies the essence of simplicity. With a small footprint, the MAXX-606/607 is a laser diode modular design that allows for low-cost maintenance and replacement components. The unit features 635nm red, 520nm green, and 450nm blue lasers. Simple controls permit for facility of use. The MAXX-606/607 includes a two-year warranty from Cemar Electro Inc. The purpose of this manual is to provide instructions on the installation and setup of the patient positioning lasers within the treatment room. Note: This Installation and Set-up Manual pertains to the MAXX-606/607 laser, which is similar to but not identical in configuration to the CL-606 model or the MAXX-700 series. Please ensure to follow these instructions for the MAXX-606/607 Patient Positioning Laser only.

5 SECTION 2: INTENDED USAGE The intended use for the MAXX-606/607 patient positioning laser is to align patients to medical diagnostic imaging and radiation therapy equipment utilizing ionizing radiation. MAXX-606/607 lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied. Note: Use of the MAXX-606/607 laser system other than its intended use is carried out entirely at the user's risk. Page 5

6 SECTION 3: LASER SAFETY CONSIDERATIONS To help ensure safe operation of your MAXX-606/607 system, please read this section carefully and follow the instructions and procedures in this manual before installing and operating the units. 3.1 SIGNAL WORDS Signal words are used according to international standards throughout this manual. The meanings of these signal words are: DANGER: Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. This signal word is to be limited to the most extreme situations. WARNING: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. Permitted for property-damage only accidents. 3.2 GENERAL SAFETY The MAXX-606/607 is a Class 2 laser product which meets the requirements of IEC/EN :2014. The American National Standards Institute (ANSI) notes that Class 2 lasers are CW and repetitively pulsed lasers with wavelengths between 0.4 µm and 0.7 µm that can emit energy in excess of the Class 1 AEL, but do not exceed the Class 1 AEL for an emission duration less than 0.25 seconds and have an average radiant power of 1mW or less. WARNING: Risk of incorrect diagnosis or treatment. Isocentre of alignment lasers must coincide with isocentre of diagnostic or treatment equipment. Testing the alignment of lasers to isocentre of diagnostic or treatment equipment is based on hospital procedures. Newly installed equipment can possibly shift as building walls and floor settle and as building materials dry out. Realign lasers to isocentre before use, if they have moved. CAUTION: Laser light, risk of eye damage. To prevent eye damage, physicians, patients, and/or operators should not stare into laser beam. The normal blink reflex will prevent eye damage; however, if a patient is unable to blink normally the laser operator must prevent laser from shining in patient's eye. Replace laser diode only with assembly provided by Cemar Electro Inc. to ensure that laser power levels do not exceed class II limits. Comment [KO3]: Please validate whether this description is legally accurate as concerns the MAXX-606. Comment [MS4]: I will be changing the Classification to Class 2M. This will require the addition of a description of the implications. Page 6

7 3.3 PROTECTIVE EYEWEAR Protective eyewear is not necessary for typical applications where direct papillary impingement by the beams is a random momentary event. Under typical conditions requiring more protracted ocular exposure, protective eyewear or other protective measures may be required. Consult the user standards of the ANSI for further guidance ( Comment [KO5]: Please confirm whether this applies. Comment [MS6]: Yes, this still applies 3.4 LASER SPECIFICATIONS Specifications for MAXX-606/607 are as follows: External Housing Specifications Housing Dimensions Housing Material Exit Aperture Protection mm x mm x mm (1.81 kg) Aluminum Hard black anodized T6061 Electrically isolated Window Electrical Specifications Operating Voltage V AC Load Current 1.0A Power Consumption Power Supply Interconnect Cable 1 W 110/240V AC 50-60Hz 12.0V DC-0.8A 6ft DC input Environmental Specifications Operating Temperature Storage Temperature Dust/Water Resistant 15 C to 35 C (59 F to 95 F) -40 C to 80 C (-40 F to 176 F) IP50 Page 7

8 Optical Specifications Wavelengths Wavelength Stability 635nm (red), 520nm (green), and 450nm (blue) wavelengths 0.3nm/ C nominal Optical Output Power Power Output Stability at 25 C 1 mw to 10mW (at the exit aperture) ± 1% Line Generator Customized, fan angle 60 Spot Size Beam Divergence Focal Distance Line Thickness Line Thickness Divergence Line Intensity Profile Lens Material Not applicable < 5 mrad User defined 1 3 m distance 10 (@1/e²) < 1 mrad Gaussian Glass Pointing Specifications Accuracy Stability vs. Temperature < 1 mrad < 10 µrad/ C Reliability/Regulatory Specifications Laser Lifetime Expected > C Certification/Regulatory Warranty FDA/CDRH 2 years Page 8

9 3.5 SAFETY LABELS FOR MAXX-606/607 UNITS The labels on all MAXX-606/607 units are required for compliance with federal regulations. Do not remove these labels. Safety labels are located on the laser unit: Figure 3.1 Warning labels. Figure 3.2 Safety labels. Comment [KO7]: Could a higher-resolution graphic be sourced? The resolution here isn t ideal for digital or print resources. Please advise. Comment [MS8]: This label will be replaced by the Class 2M label; I am still searching for a high quality image. Page 9

10 Figure 3.3 Safety labels as displayed on MAXX-606/607 unit. 3.6 STORAGE To ensure optimal functionality of the MAXX-606/607 unit, ensure the following: Do not drop Store all components in a non-corrosive environment Maintain storage temperature between -20 C and +75 C (-4 F and 167 F) Maintain storage humidity between 20% and 85% relative humidity. Do not permit dew condensation Page 10

11 SECTION 4: POWER SUPPLY Each MAXX-606/607 laser includes a universal power supply (transformer) with an input of 100V to 240V at 50/60Hz-0.8A. A 1.2 meter (4 foot) power cord supplies 9V DC 1.7A power to the laser unit with a screwon power plug. For servicing switch off the unit and remove power from the supply using the appliance inlet. Figure 4.1. Power supply. Figure 4.2. Power controls. Page 11

12 SECTION 5: TREATMENT ROOM PREPARATION Before the MAXX-606/607 can be correctly installed in the treatment room, the system isocenter must first be identified. Once identified, appropriate reference marks should be placed on the wall to determine the precise location of the mounting, as well as aid in the alignment of the laser lines once the lasers have been installed. Accurate positioning is crucial; failure in installation can result in inaccurate laser readings. Please contact Cemar Electro Inc. if you wish to coordinate installation by one of our professionals. Comment [KO9]: Please confirm whether the description below is accurate for the MAXX-606. Comment [MS10]: Yes this is accurate Figure 5.1. Typical room layout. Page 12

13 5.1 GENERAL ROOM LAYOUT Correct treatment room set-up is crucial to the successful installation of a patient positioning laser system. Preparation work on the treatment room should be completed before the system components are shipped to the installation site. Necessary preparation work comprises: Establishing where various system components will be located within the room Determining the mounting configuration for each laser unit Providing an adequate structure to mount all of the laser units in the system Determining routings for cables Establishing necessary power for the system In the case where the treatment room is not yet constructed, Cemar Electro Inc. recommends that a rigid steel support frame for the moving lasers is incorporated into the room construction. 5.2 ROOM SPECIFICATIONS The treatment room must meet the following specifications to permit for installation of the MAXX-606/607 unit. Treatment Room Specifications Category Feature Specification Electrical Mechanical Power supply Laser unit dimensions Weight V AC, 1.0A, 50-60Hz Output voltage: 12.0V DC-0.8A Length: mm (8.2 in) Width: mm (4.6 in) Height: mm (3.9 in) 1.81 kg (4 lbs) Environmental Room size 10 by 16 by 7.5 Operating temperature Others 15 C to 35 C (59 F to 95 F) No flammable anaesthetics No corrosives Comment [KO11]: Is this room size correct? Please advise. Comment [MS12]: This is a typical room size maybe it should less restrictive. Page 13

14 SECTION 6: LASER INSTALLATION 6.1 PRE-INSTALLATION The MAXX-606/607 Patient Positioning Laser System provides an optical aid for rapid, accurate patient positioning and repositioning for therapy and simulator machines. Various combinations of the MAXX-606 (crosshair) and the MAXX-607 (sagittal) are used with different systems. Option 1. Two MAXX-606 crosshair lasers mounted on each side beam crosshairs along the X-axis. Option 2. One MAXX-606 crosshair laser mounted on the ceiling beams a crosshair vertically along the Z-axis. Option 3. The MAXX-607 sagittal laser beams a straight line in the Z-Y plane. 6.2 INSTALLATION INSTRUCTIONS The following instructions do not supersede hospital procedure for room laser setup and are suggested procedure only. Step 1. Step 2. Step 3. Step 4. Step 5. Step MOUNTING OPTIONS Scan a phantom to determine ISO center. Install MAXX-607 (sagittal) laser according to the phantom location and indication marks. Rotate head and project to wall locations to mount MAXX-606 (crosshair) lasers. Optional laser level or water levels may be used for accuracy. Verify all laser intersections. Lasers should be installed as co-planer with no parallax. Steel or aluminum base plates must be installed in the walls and ceiling where laser units are to be mounted. The location, size, and stability of these base plates is critical to a satisfactory installation of a patient positioning laser system. Lasers can be installed to either mounting plates (Figure 6.1) or adjustable mounting brackets (Figure 6.2). Comment [KO13]: Please validate whether steps are correct. Going by the options listed above, it s not clear why the 607 and 606 would both be needed. Maybe we can rephrase this section for clarity. Comment [MS14]: It ultimately is up to the installer to decide which lasers to install first and the physicist to dictate how many lasers to install. The sagittal laser helps with highlighting areas with high contours (i.e. bellies). The optional laser level and water levels are aids used to install our lasers more accurately. Comment [KO15]: Co-planner and parallax have not been defined. Should these terms be clarified? Please provide definitions if yes. Comment [MS16]: These should not need clarification unless you would like to create a glossary for clarification purposes. Page 14

15 Figure 6.1. Mounting plate. For the MAXX-606 laser, mount plates (Figure 6.1) to walls first, then attach the MAXX-606 laser units to the plates. Figure 6.2. Mounting brackets (front and side). Max 45º Adjustable mounting brackets can be used to install all units. Cemar Electro Inc. highly recommends using these specific brackets for ceiling-mounted crosshair laser (MAXX-606- CHG) as well as sagittal laser (MAXX-607-SAG). Note: The mounting bracket can be adjusted to a maximum of 45º. Page 15

16 6.3 OPERATOR CONTROLS Operator controls facilitate the movement and operation of the patient positioning laser. Option 1. All lasers are connected to one wall switch; lasers can be powered on and off simultaneously from a single convenient location. Option 2. Lasers are connected to a timer so that the lasers are automatically turned on or off at a set time. Figure 6.3. Overview of operator controls. Page 16

17 SECTION 7: SYSTEM MAINTENANCE 7.1 REPAIR AND SERVICING WARNING: Only certified Cemar Electro Inc. technicians should carry out any repairs to your laser units other than changing the laser module if authorized, note replacement of the laser module will affect the 90º angle in the cross. Note: Without written permission of Cemar Electro Inc., any unauthorized repairs to the laser unit can cause further damages and will result in the warranty extended by Cemar Electro Inc. to be rendered null and void. 7.2 MAINTENANCE AND CLEANING Once installed, the MAXX-606/607 laser require no maintenance other than light cleaning. All cleaning efforts should be undertaken with a soft lint-free cloth and, if necessary, mild soap containing no ammonia or abrasives. Occasional outside dusting of the antireflective window in the cover may be necessary. Use only standard lens cleaner with clean wipes. Clean other outside surfaces of the laser unit with a soft cloth slightly moistened with water or a mild detergent solution and then wipe the surface with a dry cloth. Do not use any type of abrasive pad, scouring powder or chemical solvent such as thinner, benzene, alcohol, or disposable wipes as these may damage the finish. In case that a laser fails to function properly, please contact Cemar Electro Inc. Customer Service as soon as possible (see Section 8.2 for Contact Information). Page 17

18 SECTION 8: TECHNICAL SUPPORT AND CUSTOMER SERVICE 8.1 TECHNICAL SUPPORT Cemar Electro Inc. Service Representatives are available to work with facility planners, architects, and hospital personnel throughout the planning and installation process. 8.2 CUSTOMER SERVICE Cemar Electro Inc. is committed to satisfying our customer s needs. If you have any questions, comments or suggestions regarding our products and service, please call or us. Please contact a Cemar Electro Inc. distributor or our representative for a quotation or for a detailed description of our ordering policies, warranties, delivery policy, conditions of sale, damaged goods policy, and returned goods policy. 8.3 CONTACT INFORMATION In the United States and Canada, Cemar Electro Inc. Sales & Service Department hours are: 8.00 a.m. through 4.30 p.m. (Eastern Standard Time). U.S.A. Cemar Electro Inc. 100 Walnut Street Champlain, New York 12919, USA ph: fax: toll free: Canada Cemar Electro Inc th Ave, Lachine, QC H8T 3J8 Canada ph: fax: toll free: Page 18

19 SECTION 9: WARRANTY Cemar Electro Inc. warrants its patient positioning equipment to be free from defects in materials and workmanship under normal use and service for two years from the date of shipment. The sole obligation of Cemar Electro Inc. under this warranty is to repair or replace without charge or to refund the purchase price, at the option of Cemar Electro Inc., of any parts which its examination shall have disclosed to be defective, provided that buyer shall have given to Cemar Electro Inc. a written notice of the claimed defect no later than seven days after the end of the warranty period (two years of the date of shipment of such equipment to buyer). At the request of Cemar Electro Inc., the buyer, at their expense, shall return the claimed defective part to Cemar Electro Inc. DISCLAIMER OF OTHER WARRANTIES The aforesaid warranty rights are buyer's exclusive remedies and are in lieu of any other remedies, obligations, or rights, including, without limitation, any other warranties, expressed or implied (e.g., implied warranties of merchantability or fitness for a particular purpose). Under no circumstances shall Cemar Electro Inc. be liable for any incidental, indirect, special, or consequential damages or for any other loss, damage, penalty, or expense of any kind including, without limitation, loss of profits or overhead, reimbursement, personal injury, or property damage. The aforesaid warranty obligation of Cemar Electro Inc. constitutes its sole liability and under no circumstances shall the maximum liability of Cemar Electro Inc., under any legal theory (e.g., contract, warranty, negligence, promissory estoppel, strict liability, misrepresentation, tort) and for any reason whatsoever (e.g., defect, delay, or otherwise) exceed the purchase price of the defective part regardless whether the claim is asserted by buyer or any other person or entity. The liabilities of Cemar Electro Inc. as above set forth, shall not be extended because of advice given by it in connection with the design, installation, or use of the equipment or parts therefore. Page 19